Prescription drug · ANDA
Tavaborole NDC 70771-1826
Tavaborole 43.5 mg/mL · Solution · Topical · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1826-0 | 7077118260070771182600 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (70771-1826-0) / 10 mL in 1 BOTTLE, WITH APPLICATORMarketed from Apr 24, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tavaborole
- Generic name (nonproprietary)
- tavaborole
- Active ingredients
- Tavaborole — 43.5 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212294
- Marketing start
- Listing expires
- Other FDA classes
- Boron Compounds (Chemical structure)Protein Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1826_b7ea9baf-cd2b-4430-a0cf-85945ce38a17SPL ID b7ea9baf-cd2b-4430-a0cf-85945ce38a17SPL set ID 15bc62dc-4f5e-4d43-a125-d1f00bee84a5RxCUI 1543177UNII K124A4EUQ3
- Pharmacologic class
- Oxaborole Antifungal
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470771182600followed by a unit qualifier and the quantityPackage 70771-1826-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
About NDC 70771-1826
- What is NDC 70771-1826?
- 70771-1826 is the product NDC for Tavaborole, Tavaborole 43.5 mg/mL solution, listed with the FDA by Zydus Lifesciences Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tavaborole.
- What is the active ingredient?
- Tavaborole.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tavaborole?
- 6 other product NDCs are listed under this name. See all Tavaborole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tavaborole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Limited | 46708-467 | 46708-0467-0446708-0467-10 |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Viona Pharmaceuticals Inc | 72578-102 | 72578-0102-04 |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Chartwell RX, LLC | 62135-663 | 62135-0663-59 |
| tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Mayne Pharma Commercial LLC | 51862-690 | — |
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Alembic Pharmaceuticals Inc. | 62332-467 | 62332-0467-0462332-0467-10 |
| Tavaboroletavaborole topical solution, 5% | Tavaborole 43.5 mg/mL | SolutionTopical | Encube Ethicals, Inc. | 21922-020 | 21922-0020-12 |
Other NDCs under ANDA 212294
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tavaborole | Tavaborole 43.5 mg/mL | SolutionTopical | Viona Pharmaceuticals Inc | 72578-102 |